Non-invasive Evaluation Program for TIPS and Follow Up Network (NEPTUN)

May 11, 2020 updated by: Jonel Trebicka, University Hospital, Bonn

Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol

Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

Study Overview

Status

Completed

Conditions

Detailed Description

NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.

Study Type

Observational

Enrollment (Actual)

747

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany
        • University Hospital Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients receiving TIPS according to guidelines

Description

Inclusion Criteria:

  • Insertion of TIPS according to guidelines

Exclusion Criteria:

  • Contraindication for TIPS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Retrospective 1
Retrospective Bare Metal Stent Cohort that received TIPS from 01/01/1996 to 12/31/2003.
Retrospective 2
Retrospective Covered Stent Cohort that received TIPS from 01/01/2004 to 12/31/2012.
Prospective
Prospective cohort that received TIPS from 01/01/2013 onwards

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: up to 10 years
death, liver transplantation
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variceal Bleeding
Time Frame: up to 10 years
Assessment of presence of variceal bleeding
up to 10 years
Liver Failure
Time Frame: up to 10 years
defined as Bilirubin level ≥ 12mg/dl
up to 10 years
Ascites
Time Frame: up to 10 years
Evaluation of amount of ascites according to the Child-Score
up to 10 years
Hepatic Encephalopathy
Time Frame: up to 10 years
Evaluation of the grade according to the West Haven Criteria
up to 10 years
Acute-on-Chronic-Liver Failure (ACLF)
Time Frame: up to 10 years
Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria
up to 10 years
Organ Failures
Time Frame: up to 10 years

Assessment of Organ failures according to the CLIF-SOFA

according to CLIF-Sequential Organ Failure Assessment (SOFA) Score
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Michael Praktiknjo, MD, University of Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 1999

Primary Completion (ACTUAL)

May 11, 2020

Study Completion (ACTUAL)

May 11, 2020

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (ACTUAL)

August 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEPTUN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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